Naloxone auto-injector approval important step to saving lives

The first auto-injector for naloxone, an overdose reversal medication, was approved by the Food and Drug Administration (FDA) on April 3. The consumer-friendly device will be available by prescription only, and the main target is family members and caregivers of patients prescribed opioids. Naloxone reverses the effects of opioids and has already saved thousands of lives used by syringe injections or intranasal spray, especially by harm reduction advocates who target street overdoses of heroin.

The auto-injector, called Evzio and fast-tracked by the FDA because of the opioid overdose epidemic, works on all opioids, heroin and prescription medications. But because five times as many deaths occur on prescription opioids compared to heroin, Evzio fills a much-needed gap, federal officials said.

“People are dying,” said Margaret A. Hamburg, M.D., commissioner of the FDA, in a press call announcing the approval. And she stressed that anybody can use Evzio–not only the person it is prescribed for. “We recognize that sometimes this will be used in the context of a specific patient, but we have no intention of prohibiting the use of naloxone by first responders, family members, caregivers, and anyone for whom a product wasn’t prescribed,” said Hamburg.

The naloxone auto-injector is an “important new tool,” said Douglas Throckmorton, M.D., deputy director of regulatory programs at the FDA. And while the “larger goal” is to prevent opioid addiction and abuse, the auto-injector will help save lives, he said. But use does not negate the need for 911 calls when Evzio is used.

There are many jurisdictions in which first responders and harm reduction advocates carry intranasal naloxone spray--or rather, they carry the liquid in a vial, and then use an atomizer which they can use to spray it into the nasal passages. It’s an off-label, makeshift use, but it works. The main other delivery device is via syringe, which requires medical training.

The auto-injector provides another option, said Michael Botticelli, director of the Office of National Drug Control Policy, adding that for many people, law enforcement is the first responder to an overdose. Whether they use the new auto-injector or other devices, all first responders should carry naloxone, he said. “We encourage law enforcement to train and equip first responders” with naloxone, said Botticelli. “We know they understand that saving a life is more important than making an arrest.”Obviously, emergency medical technicians are able to use the syringe but in many cases, it will be easier for non-medical first responders to use an auto-injector, or intranasal spray.

Intranasal formulation work in progress

Wilson Compton, M.D., deputy director of the National Institute on Drug Abuse (NIDA), called the auto-injector a “milestone.” At the same time, he said that NIDA is working on research on intranasal formulations. “This is a situation where states and local practitioners have been ahead of the developers,” said Compton. “That’s why we’re working so hard at NIDA to develop an intranasal formulation that can be approved by the FDA,” he said.

Harm reduction advocates have come up with other ways to deliver naloxone to overdose victims, including the makeshift liquid and atomizer kits. “Faced with an epidemic of overdoses, the field has gotten ahead of the FDA,” said Melinda Campopiano, M.D., medical officer for Substance Abuse and Mental Health Service Administration’s (SAMHSA) Center for Substance Abuse Treatment. The hope is that with an easier-to-use FDA-approved device, uptake of naloxone prescribing whether due to illicit drug use or prescriptions will increase, she added. Last fall, SAMHSA released an opioid overdose prevention manual, which provides advice about when to administer naloxone.

Treatment itself is an overdose reduction strategy, noted Botticelli, who said that when Baltimore, a city with a high rate of heroin addiction, expanded buprenorphine treatment, there was a reduction in overdose deaths. “We are looking at how to continue the focus on the uptake of medication-assisted treatment,” said Botticelli. “We’re also looking at innovative models to expand access, particularly to buprenorphine, and some other work we’re doing to expand access to medication-assisted treatment.”

According to NIDA’s Compton said that there are many barriers to medication-assisted treatment, including requirements that patients fail at other less expensive treatments or have onerous co-pays. “We’re working on this,” he said.

Critics of widespread availability of naloxone – including the governor of heroin-ravaged Maine--think that it will encourage drug use. There is no evidence of this, said the FDA’s Throckmorton. “First and foremost, this is about saving a life,” he said. Secondly, going through withdrawal, which naloxone would precipitate in a regular opioid user, is “not a pleasant experience,” he said. “That would serve as a disincentive” to use naloxone as a mechanism to continue abuse. Instead, the rescue should lead the person to seek medical attention and “discuss what led you to overdose on your prescription drug,” he said.